MoH: Sinovac, AstraZeneca vaccines get conditional approval for use as booster shots

KUALA LUMPUR (Nov 18): Malaysia's Drug Control Authority (DCA) has given conditional approval to the Covid-19 vaccines from Sinovac and AstraZeneca to be used as booster shots, according to the Ministry of Health (MoH).

MoH director-general Tan Sri Dr Noor Hisham Abdullah said approval had been given for the two vaccines to be used as booster doses for individuals aged 18 years and above who had received vaccines of the same type (homologous).

"The booster dose for AstraZeneca's vaccine is administered six months after the receipt of the second dose of vaccine, while the booster dose for [Sinovac] CoronaVac's vaccine is administered three to six months after the receipt of the second dose.

"The administration of booster doses of these two vaccines to specific target groups will be detailed by the Covid-19 Immunisation Task Force (CITF-B) and will be announced from time to time," said Dr Noor Hisham in a statement on Wednesday (Nov 17).

Health Minister Khairy Jamaluddin shared in a tweet: "Sinovac and AstraZeneca [vaccine] booster have gotten regulatory approval which paves way for the Vaccination Technical Working Group to make recommendations on who qualifies to receive the shot under the heterologous booster programme."

The approval for these two vaccines to be used as booster shots came after the DCA granted the same for Pfizer's Comirnaty vaccine last month.

Meanwhile, the DCA has also agreed to grant conditional registration approval for the AstraZeneca vaccine from a third manufacturer, namely SK Bioscience Co Ltd in South Korea, said Dr Noor Hisham. The registration holder for this vaccine is AstraZeneca Sdn Bhd.

He said the first manufacturer who obtained the conditional registration approval from DCA was AstraZeneca Nijmegen BV in the Netherlands, while the second manufacturer was Siam Bioscience Co Ltd in Thailand.

"MoH would like to inform that this conditional registration approval requires information on the quality, safety, and effectiveness of the vaccine product to be monitored and evaluated based on the latest data from time to time. It is to ensure that the comparison of benefits over risks for the vaccine remains positive.

"MoH is also always committed to improving access to Covid-19 vaccine products in Malaysia, by ensuring that they have been evaluated in terms of quality, safety, and effectiveness by the NPRA (National Pharmaceutical Regulatory Agency) and approved by the DCA," Dr Noor Hisham added.

A total of 22,332,571 individuals or 95.4% of Malaysia's adult population had completed the two-dose vaccine regime as of Tuesday (Nov 16).

Based on the MoH's COVIDNOW portal, they were among 22,882,504 individuals or 97.7% of the adult population who had received at least one vaccine dose.

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